Category Archives: Calibration

Rotronic has released launched our next generation server based Environmental Monitoring System (RMS), but here we take a look at our traditional system that is still fully supported and widely used in the pharmaceutical industry and beyond.

The German pharmaceutical manufacturer Dr. R. Pfleger GmbH requires specialist cleanroom environments for many areas of production and development. It is vital for the company to monitor and verify pressure conditions as well as humidity and temperature data in its cleanrooms. To meet this need,the company uses validated Rotronic data loggers from the Hygrolog HL-NT series.

Together with theRotronicvalidated HW4 monitoring software, these data loggers deliver important information on the environments that have an influence on the production of pharmaceutical products.

The Rotronic monitoring system has stood the test of time in the market over many years and undergone continuous development. The HW4 software forms the heart of the system. It visualises and saves all data, configurations and user events and also triggers alarms. Its audit trail logs all data and activities in compliance with FDA21 CFR Part 11 and GAMP5. Rotronic calibrated, qualified and validated Dr. R. Pfleger GmbH’s monitoring system according to GMP requirements.

Overall control and regulation
The management system forms the basis for operation, monitoring and control of the technical facilities as well as for data and message management. Apart from the technical installations, the validated clean room monitoring system is implemented
directly in FIS (OPC interface).

HygroLog HL-NT data logger – The central acquisition unit is a HygroLog-HL-NT data logger. It provides digital inputs for HygroClip humidity and temperature probes as well as Pt100 and 4…20 mA devices.

The data logger is also equipped with a memory card which not only stores the measurement of data but also all the events in the instrument itself.

HC2-S sensors
The digital HygroClip2 climate probes provide class leading precision and long-term stability. All calibration and adjustment data is stored internally. Their standard accuracy ex works is ±0.8 %rh and ±0.1 K, for more demanding tasks, sensors with an accuracy of ±0.5 %rh can be supplied.

Sophisticated Software – The HW4 software saves the measurement data, alarms and events in a protected binary format. Any manipulations are detected and the data record is then marked as corrupt. Instruments are organised in groups and shown in the room layout. Colour changes make alarms and disturbances easy to recognise.

Evaluation and archiving
A data file is created for every measuring point. Mean Kinetic Temperature values are calculated from this raw data. The evaluation also contains alarm times and deviations and is presented in the form of a table with statistical values. Thanks to the high level of integration of the hardware in HW4, virtually all Rotronic instruments can be implemented in the existing monitoring system.

Customer benefits
The monitoring system implemented by Rotronic offers a consistent solution, since all main and secondary installations and the monitoring system itself are integrated in the FIS management system, they can be monitored and controlled via a central software platform.

JOWA AG Pasta has been the largest manufacturer of pasta products in Switzerland since it was founded in 1931. It is important for the company that its production operations run smoothly and meet strict quality standards.

Precision temperature and humidity probes from Rotronic are used to measure the climates in the factory’s six production lines, which predominantly manufacture dried pasta for the retailers such as Migros (Switzerland’s largest retailer). As a testament to the quality of Rotronic probes some units are over 15 years old and are still performing as required having only undergone routine calibration and adjustment to ensure that they provide consistently accurate accurate data.

JOWA AG manufactures 18,000 tonnes of pasta per year and is thus the largest pasta producer in Switzerland!

The pasta market is highly competitive and food legislation strict. It is therefore all the more important that the pasta is produced in the finest quality without production stoppages and rejects. The drying process plays a key role in the production of dried pasta and is therefore accorded top priority at JOWA. In order to control the climates optimally, temperature and humidity probes from Rotronic are used in the production lines. To preserve the food for a long shelf life and prevent mould and negative microbiological processes, the pasta is dried to a very specific level. Over drying wastes time, energy and produces a poorer quality product, under drying reduces shelf life and risks spoilage. Humidity and temperatures therefore need to be monitored closely during production. Legislation in Switzerland states that pasta products may not contain more than 13 percent water.

High Demands on Probe Accuracy

JOWA has been manufacturing pasta at its site in Buchs AG since 1963. The requirements of food standards, law and customers are rising continuously.

“Every single production step needs to be traceable in ever more detail, down to each single packet of spaghetti. The temperature and humidity of each production step must be recorded exactly.”

If unwanted temperature and humidity variations were to occur in the pasta, this could lead to quality defects such as crumbling. The pasta would then dry irregularly and break during cooking. For this reason a sample is taken of every product from the first three and last three pallets for quality assessment. The heads of the different departments evaluate the products daily according to various specified properties such as taste and appearance.

Oliver Höfler explains: “If we have to recall products from various stores, this means an enormous financial loss of several ten thousand francs and also a severe blow to the image of our products. A dissatisfied customer – that is something we cannot afford. For this reason it is essential that we are able to rely on the measuring accuracy of the Rotronic probes to 100 percent.”

In addition to this, samples need to be taken for analysis from ongoing production every four hours. “ We greatly appreciated the open and transparent collaboration with Rotronic.” Oliver Höfler, JOWA AG, Switzerland Migros dried pasta perfectly monitored. Rotronic I200 sensor, providing reliable service for more than 15 years.

Project Workflow: Good and Long-Term Planning

Planning calibration time is the key to success with humidity instruments. JOWA AG in Buchs stops production twice a year, two weeks in winter and two weeks in summer, in order to check all equipment and machinery and so maintain the high quality standards. Andreas Zülle, head of production, ensured that the 50 probes (both the I200 transmitters dating back to at least the year 2000 and the newer HygroFlex5 generation) were disconnected right at the start of the last inspection so that Marko Schulze, Rotronic’s qualification technician on site, could begin calibrating the measuring devices. All probes were also catalogued. Marko Schulze: “JOWA’s planning was ideal, I was able to check all probes and either get them back into shape or replace them, and then we still had enough time to test the newly adjusted probes.”

Smooth implementation of the inspection and calibration procedure was important to Andreas Zülle: “After the calibration, our process specialists were able to start up the production lines again without problem.” Oliver Höfler adds: “We greatly appreciated the open and transparent collaboration with Rotronic, found Marko Schulze to be an extremely competent partner and are sure we will be able to carry out calibration of our instruments even more efficiently next time. They have now been catalogued in detail. On top of that, we can also check the probes during operation with the Hygropalm from Rotronic.” Both sides benefit from good planning and a good working relationship.

Some Interesting Facts about Jowa

JOWA Pasta has been producing dried pasta for more than 50 years

The durum wheat semolina needed for production comes from a mill in Wildegg that also belongs to JOWA.

A team of 46, working three shifts a day, ensure daily that high-quality raw materials are transformed into products at an optimum price-performance ratio .

JOWA employs a workforce of around 3,200 people and, with more than 140 apprentices and trainees, is the biggest training company in the Swiss bakery industry.

JOWA AG is the leading Swiss bakery and supplies its customers from the retail trade, convenience stores and food service sector daily with a wide range of products and individual service concepts.

Rotronic, the largest Swiss manufacturer of products sold worldwide for the measurement of temperature and humidity, low dew point, CO2, differential pressure and airflow, has developed a complete new continuous monitoring system. The Rotronic Monitoring System (RMS) checks, documents and visualises all required measurements in one place and makes them available to the user in the desired form. The data can be retrieved from anywhere, at any time by PC, Mac, tablet or smartphone. The system offers the highest level of performance, flexibility, versatility yet is easy to set up and operate.

The new Rotronic Monitoring system (RMS) provides one complete, flexible and yet simple environmental monitoring solution instead of many fragmented and complex systems working in isolation. The RMS software stores all recorded measurements securely in a system that the user can access at any time, data can be retrieved in any form and integrated into 3rd party systems, automated reports are easily generated and sent autonomously to key personnel. The heart of the system is server based web software with a secure SQL database. It records all data and events generating a range of alerts or warnings when customer defined criteria are breached. The RMS data loggers transmit the measured values to the software via wireless or LAN communication. The system has already been extensively tested successfully and proven its worth in large scale projects from global pharmaceuticals to local manufacturing companies. Customer feedback has enabled the system to continue to evolve, further enhancing many key features.

RMS is Highly Versatile

The modular system is suitable for use in laboratories, cleanrooms as well as production and manufacturing processes, stability cabinets and storage facilities throughout the food, pharmaceutical, biotechnology and cosmetic industries. It is highly suitable for monitoring data reliably for building management systems, across industry, museums and art galleries, archive stores and during the transportation of valuable products that are sensitive to variations in humidity and temperature levels. Data loggers record all data continuously with temperature, humidity and many other parameters. Third-party devices and existing systems can be integrated easily, making the RMS extremely flexible and allowing trouble-free expansion at any time. The system sends error messages and alerts by voice call, e-mail or SMS text messages as well as smartphone apps and switch outputs.

RMS has a Wide Reach and Data is Secure

Whether the user is abroad travelling, or working in an adjacent room access to the real-time data is guaranteed at all times. Control and monitoring is possible at any time via PC, Mac, tablet or smartphone. This gives peace of mind and also saves costs. Thanks to the SQL server database and the latest ASP.NET server software, high availability of the data is guaranteed and data security ensured by https protocols – regardless of the location or terminal device. It is also possible to encrypt all data.

RMS Meets All Regulatory Requirements

The new Rotronic Monitoring System meets all the regulatory requirements of GxP, FDA Annex 11, 21 CFR 11 and GAMP5. Thanks to the technical experts in the research and development department at Rotronic, installation is simple and uncomplicated. Local support is available through a worldwide network of Rotronic subsidiary companies and distributors.

For many years Rotronic products have been widely used in the monitoring and control of clean rooms, however more often than not our products are found out of sight quietly performing their measurement tasks away from areas with strict requirements for cleanliness demanded by modern clean rooms.

In the past few months Rotronic have launched two new clean room panels that are as the name suggests designed specifically for use within clean room environments.

Our flagship product in the field is the CRP5 which we will take a look at first.

CRP5 – Clean room From Rotronic

The CRP5 is a comprehensive clean room panel designed specifically for the requirements of modern clean rooms. Once installed the unit provides virtually no areas for dust to collect and the industrial glass front is extremely resistant to chemicals. With a fully configurable colour screen it is a stylish looking device!

Unpacking the CRP5, the glass front, colour display and stainless steel fittings make the CRP5 elegant, easy to clean and functional

A unique feature of the CRP5 is the optional flush mount humidity probe. The probe is locked into place through the use of magnets and can easily be removed for cleaning or calibration. An optional rear mount connection is available for Rotronic HC2 humidity and temperature probes should you wish to monitor ducts or spaces remote to the CRP5 itself.

The unique removable Humidity and Temperature probe for ease of cleaning and calibration

The configurable colour display shows alarm conditions which can be acknowledged via the front panel. Alarms can be used to trigger relays associated with audible and larger visitual alarms. Interaction with the CRP5 is via four optical buttons – their use is completely unaffected if operators are wearing protective gloves or not (unlike capacitive interfaces).

Optical buttons can be used easily even when wearing gloves!

As an FDA and Gamp5 compliant device the CRP5 is a safe choice for regulated industries. The instrument can be used with 3rd party systems via its analogue outputs or industry standard Modbus TCP / RTU communication. Alternatively the CRP5 can be connected to the Rotronic HW4 software package to provide a one stop solution for monitoring, control and alarming. Pharmaceutical validation services as well as ISO 17025 (UKAS) calibrations are available from Rotronic if required.

Next time we will look at the Rotronic CRP1 a dedicated temperature and humidity clean room panel for applications with slightly simpler requirements but still demanding a clean installation and high accuracy measurements!

Rotronic is proud to be able to offer an increasing range of products and services to meet the demands of our customers. The requirements for mapping especially thermal mapping are increasing dramatically in food, pharma and cosmetics production and transport industries.

But what is Thermal Mapping?
Mapping is the process of determining the temperature and often humidity gradients within a defined space. It is a vital process when the product is regulated by government agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA). Regulated materials must not exceed strict storage conditions. Fixed limits will typically exist for humidity and temperature both in terms of the absolute value and also the allowable rates of change. Mapping serves as a baseline for proving compliance within the storage spaces.

The reason for increasing regulatory compliance is to ensure products do not spoil or otherwise degrade during production, storage and transport. Warehouses are notorious for having warm or cold spots that are outside of the regular control specification. A proper mapping study serves to locate these spots and either modify or avoid the problem area. Similar problems can occur during transportation so increasingly transport is at least monitored if not fully controlled and mapped.

At 4.3 million square feet, the largest warehouse in the world is the Boeing Everett factory in Everett, WA USA. It was originally designed to construct the Boeing 747.

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Mapping in GeneralA mapping strategy is needed for several reasons. It is important for regulators or quality managers to understand the philosophy employed for the mapping. A documented strategy will decrease questions from any regulators reviewing your mapping study. The strategy document also helps them understand the data that is produced by the mapping process. The document acts as a tool for collaboration as other people may suggest ideas that will make your study produce better data or make your effort more efficient.

As the mapping study progresses from start to finish, the strategy document acts as your reference guide, ensuring you remain true to the agreed upon process and do not make changes that will negatively affect the study. A typical strategy is usually comprised of a few written paragraphs that includes a description of the warehouse space, the type of equipment used, the number of sensors to be used, a general idea of the sensor placement, and the duration of the study. It is not unusual for the mapping strategy to change as it evolves. Writing a detailed document at the early stages of the project may cause re-writes that can increase the total length of the project. It is usually more efficient to fully document the warehouse mapping project after the strategy is agreed. Think of the strategy document as a proposal for your mapping team or the approval team so they can buy into and understand your mapping strategy. It may also facilitate the final approval stage, later in the project, because the auditor already understands the warehouse mapping project.

Continuous Monitoring After the Warehouse Mapping
Continuous monitoring is a best practice within controlled and regulated spaces. The mapping study will determine the hot and cold zones for “worst case” sensor placement. These worst case locations should be considered when installing a permanent, continuous monitoring system. The number of sensors used for a permanent system will be far fewer than what is required for the mapping study. In some cases, continuous monitoring may require only a few sensors once the problem areas have been determined through the mapping study. A continuous monitoring system offers peace of mind as product components, manufacturing space, or storage space are maintained and on record as meeting specified environmental conditions.

If you have any queries regarding warehouse mapping feel to get in touch and we will be happy to discuss!

We are pleased to announce our latest training course schedule for 2016. Courses include in partnership with Dave Ayres from Benrhos Ltd our practical 3 day temperature, humidity and dew point calibration and measurement uncertainty courses. In addition, for those seeking greater depth we are running dedicated courses on measurement uncertainty and ISO 17025 run by Lawrie Cronin and Dave Ayres

Colleagues from our Swiss based HQ just outside Zurich have shared with us a great example of an increasingly important application based around the monitoring of medicines in typical high street pharmacies. Pharmacies may look like they simply store medicines on normal shelves but most drugs require strictly controlled and monitored conditions to ensure they reach us in perfect condition!Read on to discover more…

Medicines are sensitive products. Moisture or excessively high or low storage temperatures, can impair their quality. Incorrectly stored medicines lose their efficacy, leading to significant health risks. Correct storage is therefore vital, offering as it does the guarantee that medicines remain safe and efficacious and retain their high quality right up to their expiry date.

Meeting GDP/GMP requirements in pharmacies

The storage of medicines is legally regulated by GDP (Good Distribution Practice) Standard 9.2 and is inspected by the responsible authorities on site.

Insulins and other liquid antibiotics for instance must be stored in medicine refrigerators at a temperature between 2 °C and 8 °C. A temperature range of 15 °C to 25 °C applies to the vast majority of other medicines.It is compulsory to document the storage conditions of all medicines.

To help fulfil the legal requirements, Rotronic has launched the new HL-1D data logger – a convenient, precise, reliable logger that is virtually tailor-made for a medicinal environment.

Rosengarten Rotpunkt pharmacy

The HL-1D data logger has undergone exhaustive testing
under real-life conditions in the Rotpunkt Rosengarten
pharmacy. With its simple handling and remarkable price-performance ratio, the logger offers great potential for any pharmacy.

The Rosengarten Rotpunkt pharmacy is deeply rooted in the community of Bassersdorf, Switzerland and has been at its present location since 1985.

In 2011, Mr. Ivan Mihajlovic took over the directorship and today runs the pharmacy with a total of 10 employees.

Mr Ivan Mihajlovic

“The quick evaluation of the data and the understandable visualization of the measurement values in a PDF report meet all QMS requirements and document the data long-term.”

Complete measurement chain

Rotronic offers complete solutions for the entire measurement chain. Even if you are already using other data loggers successfully, we have a range of innovative calibration solutions.

If you require more information or wish to discuss any monitoring, control or calibration applications you may have please do not hesitate to contact us.